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Statement of Peter Maybarduk, Director, Public Citizen’s Global Access to Medicines Program

President Barack Obama’s speech at George Washington University today, on the 24th annual World AIDS Day, follows a decade-long revolution in treatment for people living with HIV/AIDS in developing countries. Dramatic price reductions for AIDS drugs driven by generic competition have enabled that revolution, which already has saved the lives of millions. President Obama agrees that “treatment is also prevention,” thanks to new science which suggests ARV treatment can reduce the risk of transmission by 96 percent.

Unfortunately, patent monopolies and high treatment costs for newer medicines threaten to undermine the remarkable progress already achieved and impede the laudable goal of an “AIDS-free generation” announced earlier this month by U.S. Secretary of State Hillary Clinton and echoed by President Obama today.

To continue the treatment revolution and seek an end to AIDS, we need to expand generic competition.

This World AIDS Day, Public Citizen and health groups in a dozen countries have initiated an unprecedented global campaign to challenge a leading pharmaceutical company’s costly monopolistic hold on a critical HIV/AIDS treatment. The combination treatment known as lopinavir + ritonavir, patented and sold by the Chicago-based pharmaceutical giant Abbott Laboratories as Kaletra and Aluvia, is a key component of many HIV/AIDS programs worldwide.

Abbott’s anti-competitive actions are keeping prices for this important medicine high. Generic competition has driven down prices for AIDS drugs from more than $10,000 a year per person to less than $100. Yet Abbott prices Kaletra at $400 in the world’s poorest countries, and much higher – from $1,000 to around $4,000 – in other developing nations. According to a U.S. President’s Emergency Plan for AIDS Relief (PEPFAR) country report for Vietnam, “Hopes that the cost of second-line treatments would fall significantly have not been realized ... A key driver is the cost of Abbott Lopinavir/Ritonavir products.”

When it comes to access to essential medicines, price is a life-and-death matter.

As prices for older first-line AIDS drugs have tumbled, treatment has skyrocketed. More than six million people with HIV/AIDS in developing countries are now receiving treatment; very few would be receiving life-saving medicines without the plunge in prices. The same is possible for newer second- and third-line HIV medicines: Generic lopinavir + ritonavir is now available at a low cost where patent barriers can be overcome.

Abbott’s abusive practices involve more than high price. A U.S. federal grant facilitated the invention of one of Kaletra’s essential components, ritonavir. Ritonavir can work as an effective booster with other drugs, but Abbott’s monopolistic policy commonly prevents it from being used to enhance the effectiveness and lower the cost of other medicines. Ending the anti-competitive tie on ritonavir would enable new, improved co-formulations with other AIDS drugs.

As part of the global campaign, health groups in Vietnam, Indonesia and the United States are filing license requests with their governments. Compulsory licensing authorizes generic competition for products that remain on patent in exchange for a royalty payment. It is a legal tool permissible under international trade and national law (and frequently used in the United States). Health organizations in Brazil and India are filing formal challenges to Abbott’s patent claims, arguing that the company has not met national standards for patentability and therefore is not entitled to its patent monopoly. Colombian health advocates await a forthcoming judgment on their lawsuit for a compulsory license, as the government of Ecuador and health advocates in Thailand seek to expand licenses already in effect. Peruvian groups have asked Abbott to abandon new patent applications. Treatment providers in Sint Maarten (Kingdom of the Netherlands) and Malaysia and health groups in China each have filed request letters with Abbott seeking licenses to permit generic competition. More than 250 Vietnamese groups joined a similar letter to Abbott.

Working together we can expand generic competition, reduce costs and thereby expand access to the medicines we need to end AIDS.

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